I am a practicing general internist, health services researcher and pharmacoepidemiologist. My research examines three interrelated areas of medication use: (1) patient-physician communication and decision-making regarding prescription drugs, (2) population-based patterns and determinants of pharmaceutical use, and (3) the impact of changes in pharmaceutical policy on pharmaceutical expenditures and utilization. To examine these areas, I use data gathered from patient and physician surveys and secondary data sources including pharmacy and health claims and national audits of ambulatory-based care.

My first research area has examined patient-physician communication and decision-making regarding prescription drugs costs. This has been a fundamental yet little explored problem in clinical care. Out-of-pocket prescription costs are persistent source of public concern, they modify the demand for prescription drugs, and they are associated with a variety of barriers to quality of care. As a Robert Wood Johnson Clinical Scholar, I conducted a paired-survey study of patients and physicians that indicated poor patient-physician communication about out-of-pocket costs. This led to several subsequent investigations, including the identification of barriers to communication, strategies that physicians can use to assist patients burdened by out-of-pocket costs, and consideration of new ethical challenges to physicians in the era of cost-sharing. I have also undertaken a series of inquiries examining the economic implications of common clinical prescribing decisions, including the use of a fixed dose combination medicine compared with its component parts, the provision of three-month rather than one-month supplies and the use of free pharmaceutical samples. Most recently, I completed a randomized controlled trial of a behavioral intervention to reduce patients' prescription costs.

A second focus of mine has been to explore population-based patterns and determinants of pharmaceutical use. The earliest of these analyses examined the overutilization of Cyclooxygenase (Cox-2) inhibitors beyond the population that stood to gain the most from their use. Our analyses demonstrated the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally beneficial. For policy-makers, these data provide a cautionary tale, since they have implications for drug regulation, such as the level of evidence of safety and efficacy that should be required to obtain FDA approval. They also demonstrate why technology assessments, including cost-effectiveness analyses, must consider the "real-world" application of new innovations, and indeed how such applications can ultimately undermine the added value that the innovation may offer. My collaborators and I have conducted several other studies examining the diffusion and uptake of pharmaceuticals using both proprietary and public data. We are currently focused on the quality of ambulatory care, especially for chronic conditions such as asthma, diabetes, and cardiovascular disease.

My final area of investigation has examined the impact of changes in pharmaceutical policy on health expenditures, utilization and outcomes. These studies began with a major change in pharmaceutical policy, the Medicare Modernization Act Part D Prescription Drug Benefit, combined with timely access to unique data from a national retail pharmacy chain. Our analyses represented some of the first rigorous investigations of Part D since the program's inception in January 2006 and our findings have been widely used by policy-makers to understand the program's impact. More recently, my interest in regulatory policy has extended to examining FDA advisories. This work began with analyses examining risk communications regarding the use of atypical antipsychotics in the elderly with dementia and the use of rosiglitazone among patients with diabetes. Since then, we have extended this work to examine a series of other FDA advisories with a focus on those issued for psychotropic therapies.